Recall archive / FDA company announcement

VistaPharm: Sucralfate Oral Suspension 1g/10mL — FDA announcement Sep 22, 2023

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Sep 22, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Sucralfate Oral Suspension 1g/10mL
Reason: Potential contamination with Bacillus cereus
Classification: Not supplied
Recalling firm: Potential contamination with Bacillus cereus
Quantity: Not supplied
Agency-reported status: Terminated in FDA listing
Source record identifier: 25b643163e3dc348

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Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE – September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product.; The product is used as an antiulcer therapeutic and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The affected Sucralfate Oral Suspension lot is number 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, which the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.; A Contractor, Inmar, will perform this recall process, which is notifying its distributors by recall packet delivered by FEDEX Next Day Delivery and will receive an email notification as well. In addition, Inmar is arranging for the return of all recalled products. Distributors that have any bottles remaining from Sucralfate Oral Suspension Lot 810300, which is being recalled, should return to Inmar via instructions provided.

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE – September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product.; The product is used as an antiulcer therapeutic and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The affected Sucralfate Oral Suspension lot is number 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, which the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.; A Contractor, Inmar, will perform this recall process, which is notifying its distributors by recall packet delivered by FEDEX Next Day Delivery and will receive an email notification as well. In addition, Inmar is arranging for the return of all recalled products. Distributors that have any bottles remaining from Sucralfate Oral Suspension Lot 810300, which is being recalled, should return to Inmar via instructions provided.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

The product is used as an antiulcer therapeutic and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The affected Sucralfate Oral Suspension lot is number 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, which the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Fda listing date: Sep 22, 2023
Company announcement date: Sep 22, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.