The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0851-2018·Announced 2018-06-20

RIJ Pharmaceutical Recalls Senna Syrup Due to Microbial Count Deviation

RIJ Pharmaceutical LLC is recalling Senna Syrup (Sennosides A and B) due to an out-of-specification total aerobic microbial count in a water sample.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a CGMP deviation (microbial count in water) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

RIJ Pharmaceutical LLC is recalling 3,537 bottles of Senna Syrup (Sennosides A and B), 8 FL. OZ. (236 mL), manufactured by SDA Laboratories. The product is identified by Lot # 47070042 and an expiration date of 09/18. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically an out-of-specification total aerobic microbial count detected in a water sample.

The affected product was distributed nationwide in the USA. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased this specific lot of Senna Syrup should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
SENNA SYRUP (SENNOSIDES A AND B)
Brand
SENNA SYRUP
Manufacturer
RIJ Pharmaceutical LLC
Category
Drug — OTC Laxative
Hazard
Affected units
3,537

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 47070042
  • Exp. 09/18

UPCs (1)

  • 366424562082

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by RIJ Pharmaceutical LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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